Cleared Traditional

Disposable Surgical Face Mask (3P00B, C2900)

K252830 · Beatles Medical Supplies (Xiantao) Co., Ltd. · General Hospital

Jan 2026

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K252830 is an FDA 510(k) clearance for the Disposable Surgical Face Mask (3P00B, C2900), a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Beatles Medical Supplies (Xiantao) Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on January 12, 2026, 129 days after receiving the submission on September 5, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K252830 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 2025
Decision Date	January 12, 2026
Days to Decision	129 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF